* Urinary Urge Incontinence (UUI) is the involuntary urine loss associated with a strong sensation to void. * UUI usually associated with reduced bladder capacity. * The pathophysiology is unclear. * Pelvic floor muscle dysfunction and detrusor instability have been suggested as possible mechanisms. * Standard treatment includes anticholinergic medication and behavior modification. * The study aims to compare the long term effectiveness of 4 different approaches to the treatment of women with Urge Urinary Incontinence (UUI): 1. Pelvic Floor Rehabilitation (includes muscle training+behavioral intervention+bladder training) 2. Pelvic Floor muscle training alone 3. Bladder Training alone 4. Drug treatment with Tolterodine. * Study variables will include: impairment ratings, quality of life, and cost-effectiveness. * This study addresses three issues: 1. The long term efficacy and cost-effectiveness of the various treatment options. 2. To identify the factors involved in determining the effectiveness of drug or behavioral therapy. 3. The pathophysiology of UUI. By subdividing the rehabilitation group into 3 arms, we hope to shed light on the mechanism of dysfunction. A better response in one group will help localize the problem to pelvic floor muscles or to detrusor instability.
The study has 3 phases: Before treatment (phase I), immediately after 3 months of treatment (phase II), and 1 year post-entry (phase III) Women with UUI will be divided randomly into one of the four treatment groups. Every subject will participate in 4 visits. The drug group treatment consists of administration of tolterodine SR 4 mg daily for 3 months. Subjects who assigned to the pelvic floor rehabilitation, pelvic floor muscle training, and bladder training groups will be treated via 4 visits to a physical therapist, who is trained in the procedures. The chief researcher (RK) will be blinded to the treatment groups and will perform the outcome measures in all phases. Study variables will include impairment ratings, quality of life, and cost-effectiveness
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
164
Detrusitol SR 4 mg, 1 capsule for a day, 3 months.
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for educate and schedule voiding regimen.
Four visits in 3 months with pelvic floor physical therapist, who is trained in the procedure, for reinforced pelvic floor muscles.
The Pelvic floor rehabilitation protocol based on bladder training protocol and PFMT and lifestyle advice and information about good bladder and bowel habits. Four visits in 3 months was made with pelvic floor physical therapist, who is trained in the procedure.
Rehabilitation and Physical Therapy Center, Maccabi Healthcare Services
Rishon LeZiyyon, Israel
Number of micturitions in a 24 hour bladder diary and number of urge urinary incontinence episodes by subjects' reports per week.
Time frame: Phase I, II, and III
cost-effectiveness
Time frame: 1 year
Health service utilization
Time frame: 1 year
underclothing pad use
Time frame: Phase I, II, and III
change in physical activity and smoking
Time frame: Phase I, II, and III
missed days at work
Time frame: 1 year
Maximum voided volume, as obtained from 24 hours bladder diary
Time frame: Phase I, II, III
side effects from list of 10 possible effects: dry mouth, constipation, side effects from list of 10 possible effects: dry mouth, constipation, sleepiness, fatigue, blurred vision, dizziness, urinary difficulty, tachycardia, headache and low back pain
Time frame: Phase I, II, and III
quality of life measured by I-QoL
Time frame: Phase I, II, and III
visual analogue scale (VAS) use in urogynecological research
Time frame: Phase I, II, and III
Incontinence Severity Index (ISI)
Time frame: Phase I, II, and III
functional status as measured by Late Life Function and Disability Instrument
Time frame: Phase I, II, and III
Depression status as measured by Center for Epidemiological Studies Depression scale (CES-D)
Time frame: Phase I, II, and III
Cost benefit
Time frame: 1 year
Maximum voluntary contraction fo pelvic floor muscle, graded 1-5 by Oxford scale
Time frame: Phase I, II, and III
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